To: Cacaito who wrote (2162 ) 1/30/1998 1:38:00 PM From: Dr. Voodoo Respond to of 7041
Great post Cacaito. Sorry I didn't put this together sooner. I'm a little slow. Again I am not a patent lawyer I am only interpreting what I read. "Then only Gwinup and Imhof (the prior art people) could challenge the existing patent? are they alive?... "Patent again, Zonagen's patent (the Zorgniotti one) listed at least Gwinup in the references. Somebody could check if they listed Imhof." The existing patent(Zorgniotti) covers buccal administration of phentolamine as a therapy to treat ED. Notice that, he referenced Gwinup, he did not try to patent an oral formulation, when from the literature it was apparent that phentolamine was absorbed rapidly by the gut(another interpretation of the data). Why? My interpretation is that you cannot patent something that has been publicly disclosed prior to your application. You cannot patent laws of nature. I could be very wrong. Please check this out if this is a concern of yours about Zonagen, I will, just don't have time yet. IF my assumptions are correct then, the patent application will not be allowed. This gives anyone the right to make oral phentolamine formulations in any form. Currently, I am thinking of this like the "aspirin a day" treatment for stroke. Coverage by the prior patent using buccal administration was not an advisable therapy(tastes nasty and burning sensation as I recall).2. There is only one phantolamine supplier in the world and is under contract with Zonagen. Could this supplier turn around and market by themselves? 3. Zonagen's supplier is the cheapest (I do not know how he compared this to, since there are not other suppliers.) But Joe wanted to stressed that even if somebody else comes after zonagen will still be the cheapest. These are great points, and perhaps raises the issue of SGP's involvement. If you want to play with the big boys and market an unpatentable drug you had better find a way. I'm sure it's possible to make and distribute phentolamine but it would be tough to compete with the threat of SGP and an existing supplier--Just a guess. I know their are a number of generic companies out there, I just don't see they will have much to gain if they have to make the stuff from scratch, and market it against SGP. Although, $6-$7 a pill may turn out to be a dream. Comments? "Zorgniotti argue with himself if the drug works due to the receptors in the brain, he discarded that idea, but no proof about it, since he only patented the "direct" penis effect, could somebody else claim the central(brain) receptor as the real mode of action and a new patent? It is not such a weird idea because it seems (if it does) to work only in mild ED psychogenic ones." Another excellent point, and in my opinion(which ain't worth much) is just as good as any explaination for the clinical data. The simple fact is that the data says what the data says. A zillion different things could result an improvement over direct injection vs. oral. Like I said, I don't doubt anyone's data. Is there any evidence that the $10 millions from Schering are already in Zonagen hands. The PR release talk about undisclosed financial arragements. Is it possible to have a fineprint line and Schering get away with their money up to a certain date or "milestones"? I am fairly certain that their was an up front payment of 10 mil. mentioned in the press release and in SEC doc's. Payback if everything fails seems a little unlikely. Rob